Regulator plans single-window system for new drug approvals

DCGI’s proposal part of govt’s efforts to promote Make in India initiative, boost ease of doing business

According to Drug Controller General of India S. Eswara Reddy, the initiative will bridge the gap between the regulator and innovators.

New Delhi: In a move aimed at boosting the Make in India initiative, the Drug Controller General of India (DCGI) proposes to set up a single-window facility for innovators and start-ups seeking consents, approvals and information.

DCGI plans a separate public relations (PR) office which can be approached by innovators and start-ups seeking information regarding regulatory requirements for commercialization of products as well as clarifications on the Drugs and Cosmetics Act 1940 and other rules.

“The office shall guide assist and handhold investors in various phases of business life cycle as per the existing focus on Invest India/Make in India,” said an office memorandum. Mint has reviewed the copy of the memorandum.

According to S. Eswara Reddy, DCGI, the initiative will bridge the gap between the regulator and innovators. “India at present is a generic-based country, we have to encourage the industry to conduct research in India and it was seen that due to regulatory hurdles, innovation had taken a back seat. Therefore, for the growth of innovation and to address the gap between the regular and innovator, we decided to open up with the new single-window system.”

The DCGI’s office will soon create a separate portal so that people need not come to the Delhi office for approvals and regulatory issues. A guidance document for innovators is also being planned. “For ease of doing business in India and also for promotion of innovation, to support the innovators and encourage the start up companies, this was much needed. The PR office will also address public grievances. People can come without any prior appointment,” added Reddy.

The office will bring nearly all services offered by the government to businesses and investors through a single window to assess license and permit requirements to set up and operate a business in India.

“It was seen that the innovations could not be put to practice due to the lengthy regulatory procedures. The new PR office will help these start-ups and innovators to get speedy approvals,” said a senior official in the DCGI office, requesting anonymity.

“The office aims to create a business and investor friendly ecosystem by making all business and investment related regulatory services across Central, State and local governments available on a single window, thereby obviating the need for an investor or a business to visit multiple offices or a plethora of websites,” added the official.

The official said the new initiative would help turn the “Make in India” dream into a reality for the drugs and devices industry. Among other things, those visiting office would not require prior appointment, he said.

“We appreciate prompt action taken (post announcement at Hyderabad’s Bio Asia conference) to make CDSCO more friendly, communicative, with transparent collaborative working by DCGI in appointment of a public relations officer to address grievances, specifically of new investors start-ups as Make in India enabler. Indeed, the speed of responsiveness by the DCGI is a refreshing visible improvement to Association related industry issues and we hope this trend will continue and percolate down the hierarchy,” said Rajiv Nath, forum coordinator, Association of Indian Medical Device Industry (AiMed).